ID

12219

Beskrivning

Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec /Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India; ODM derived from: https://clinicaltrials.gov/show/NCT02230618

Länk

https://clinicaltrials.gov/show/NCT02230618

Nyckelord

  1. 2015-10-18 2015-10-18 -
  2. 2015-10-19 2015-10-19 - Julian Varghese
Uppladdad den

19 oktober 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes NCT02230618

Eligibility Diabetes NCT02230618

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02230618
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any study-related activities. (study-related activities are any procedures that are related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g., hba1c (glycated haemoglobin ), fpg (fasting plasma glucose), pppg (postprandial plasma glucose), severe hypoglycaemia before the start of ryzodeg therapy) can be used for baseline data
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with ryzodeg™ based on the clinical judgment of their treating physician
Beskrivning

Diabetes Mellitus, Insulin-Dependent; ryzodeg

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C3661220
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to ryzodeg™ any of the active substances or any of the excipients
Beskrivning

allergy; ryzodeg

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3661220
previous participation in this study
Beskrivning

participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Beskrivning

Clinical Research; Disruption

Datatyp

boolean

Alias
UMLS CUI [1]
C0008972
UMLS CUI [2]
C0332453
patients who are or have previously been on ryzodeg™ therapy
Beskrivning

therapy; ryzodeg

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C3661220
patients who are participating in other studies or clinical trials
Beskrivning

clinical trials other

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Beskrivning

pregnant; breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147

Similar models

Eligibility Diabetes NCT02230618

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02230618
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedures that are related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g., hba1c (glycated haemoglobin ), fpg (fasting plasma glucose), pppg (postprandial plasma glucose), severe hypoglycaemia before the start of ryzodeg therapy) can be used for baseline data
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent; ryzodeg
Item
patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with ryzodeg™ based on the clinical judgment of their treating physician
boolean
C0011854 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
allergy; ryzodeg
Item
known or suspected allergy to ryzodeg™ any of the active substances or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C3661220 (UMLS CUI [1,2])
participation status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Clinical Research; Disruption
Item
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
boolean
C0008972 (UMLS CUI [1])
C0332453 (UMLS CUI [2])
therapy; ryzodeg
Item
patients who are or have previously been on ryzodeg™ therapy
boolean
C0087111 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
clinical trials other
Item
patients who are participating in other studies or clinical trials
boolean
C2348568 (UMLS CUI [1])
pregnant; breast feeding
Item
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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